The following data is part of a premarket notification filed by Nemoto Kyorindo Co., Ltd. with the FDA for Dual Shot - Contrast Delivery System.
Device ID | K052633 |
510k Number | K052633 |
Device Name: | DUAL SHOT - CONTRAST DELIVERY SYSTEM |
Classification | Injector And Syringe, Angiographic |
Applicant | NEMOTO KYORINDO CO., LTD. 2-27-20 HONGO BUNKYO-KU Tokyo, JP 123-0033 |
Contact | Toshio Kanetaka |
Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-09-26 |
Decision Date | 2005-10-17 |
Summary: | summary |